Hot melt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. One key advantage is the ability to produce a variety of formulations, such as solid dose forms, which improve drug bioavailability. In developing an hme drug system, the glass transition and melting temperatures are critical factors. By drawing on continuous processing, hot melt extrusion is more economical and can be used for abuse deference and taste masking applications. In drug discovery and development, industry estimates that more than 50% of active pharmaceutical ingredients currently used belong to the biopharmaceutical classification. Mar 20, 2012 hot melt extrusion is extrusion compounding two or more ingredients which have been combined in defined proportions, distinguishable from their original state in that the characteristics of the whole is unique from that of the original constituents. Apply to scientist, extrusion operator, engineer and more. In this chapter, the hotmelt extrusion to date hme has emerged as a novel.
In drug discovery and development, industry estimates that more than 50% of active pharmaceutical ingredients currently used belong to the biopharmaceutical classification system ii bcs class ii, which are characterized. Hot melt extrusion is a technique for manufacturing amorphous solid dispersions in which the drug substance is melted or dissolved within a dispersion carrier and mixed to produce and stabilize the amorphous form of the drug substance. Sincethen,ithasbeenusedintheplastic,rubber, and food manufacturing industry to produce items ranging from pipes to sheets and bags. Jul 10, 2015 hot melt extrusion hme is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market. Foster delivery science operates out of a 32,000square. A full factorial experimental design with 19 experiments was used to evaluate the effect of several process variables barrel temperature. Hot melt extrusion hot melt extrusion hme is used for blending, melting, extrusion and shaping in a single step process.
Gold chemical and materials engineering, university of dayton, dayton, ohio, usa. Introduction the word extrusion is derived from the latin extrudere. Hot melt extrusion hme is one of the most widely applied processing technologies in the plastic, rubber and food industry. Various approaches have been adopted to address this including preparation of solid dispersions and solid solutions. Daniel treffer, patrick wahl, daniel markl, gerold koscher, eva roblegg, johannes g.
Over the last three decades industrial adaptability has allowed hotmelt extrusion hme to gain wide acceptance and has already established its place in the broad spectrum of manufacturing operations and pharmaceutical research developments. Microscopy techniques combine information from microscopy. Hotmelt extrusion technique was first invented for the manufacturing of lead. Downstream processing from hotmelt extrusion towards tablets. Hotmelt extrusion hme melting a substance and forcing it through an orifice under controlled conditions to form a new material is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Extrusion is a process used to create objects of a fixed crosssectional profile. Hot melt extrusion technology for continuous manufacturing. Hotmelt extrusion hme is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market. Extruders provide extensive mixing and agitation that causes deaggregation of the suspended particles in the molten polymer resulting in a uniform dispersion. Polymers for hot melt extrusion must exhibit thermoplastic characteristics and must be thermally stable at the proper extrusion temperature. Over the last three decades industrial adaptability has allowed hot melt extrusion hme to gain wide acceptance and has already established its place in the broad spectrum of manufacturing operations and pharmaceutical research developments.
Pharmaceutical applications covers the main instrumentation, operation principles and theoretical background of hme. Different ills needs different cures in blown film, clarity is often considered synonymous with quality. Hot melt extrusion an emerging drug delivery technology monika vasant pawar m. Hot melt extrusion hme is the process of applying heat and pressure to melt a polymer and forcing it through an oriice in a continuous process. Pharmaceutical hot melt extrusion market global industry. Single screw and twin screw extruder a single screw extruder consists of one rotating screw positioned inside a stationary barrel at the most fundamental level. Hot melt extrusion hme abbvie contract manufacturing. Hme has already been demonstrated as a robust, novel technique to make solid dispersions in order to provide time controlled, modified, extended, and. Use of this technology in the pharma industry has been steadily.
Scope of the study the report includes revenue generated from sales of hot melt extruders in all regions and important countries in these regions. Global pharmaceutical hot melt extrusion equipment market. Hot melt adhesive 3747 3779 3789 3797 technical data july, 2016 product description 3m hot melt adhesives are heat applied, 100% solids adhesives. Hotmelt extrusion hme is an efficient technology for producing solid molecular dispersions with considerable advantages including the absence of solvents, few processing steps, continuous. Haze can be caused either by melt fracture on the films surface or in coextrusionsby instability inside. By drawing on continuous processing, it is also more economical and can be used for abuse deference and taste masking applications. Gold rapid prototyping journal volume 20 number 3 2014 192204 193.
Hot melt extrusion hme is the process of applying heat and pressure to melt a polymer and force it though an orifice in a continuous process. Prior to joining basf, he worked for croda international in the u. Hot melt extrusion is the upgraded version of twin screw extruder with heating as an element, the whole process involves hopper for feeding the raw material along with waxes which is pre mixed in solid form. The interest in hotmelt extrusion technology for pharmaceutical applications is evident from the. Hot melt extrusion is the new mixer extrusion range that builds on the proven umang technology and its benefits. May 19, 2017 hot melt extrusion hme is the process of applying heat and pressure to melt a polymer and force it though an orifice in a continuous process. The application of hotmelt extrusion hme in the pharmaceutical industry is. One major advantage is the fact that no solvents are required. Hot melt extrusion has a comprehensive documentation, which satisfy regulatory authorities melt extrusion is a mature technology measurable parameters such as feeding rate, equipment temperatures, discharge pressure, vacuum control, etc. Hot melt extrusion hme technology has become a key solution to adding absorption for enhanced solubility. Hotmelt extrusion, solid dispersion, melt extruded tablets, drug. Hotmelt extrusion hme is one of the most widely applied processing technologies in the plastic, rubber and food industry. Functional excipients, such as surfactants, are often added to further aid in.
Hme is wellknown, developed to produce polymer products of uniform shape and density, and its industrial application dates back to the 1930s1. In the hot melt extrusion process, the formulation is processed above the glass transition temperature of the polymerapi adjuvant system to mix the active ingredient with the. You can find detailed information on our product range by looking up your industry or using our product finder. Solid dispersions can be obtained using different processes. Pharmaceutical applications of hot melt extrusion technology.
Hot melt extruder pharmaceutical machine manufacturers and. Over the last three decades industrial adaptability has allowed hotmelt extrusion hme to gain wide acceptance and has already established its place in the. Hotmelt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. Processtechnologyofhotmelt extrusionhme hotmelt extrusion technique was. Pdf hotmelt extrusion hme is a promising technology for the production of new. By drawing on continuous processing, it is also more economical and can be used for. Hme is a well known process, developed to produce polymer products of uniform shape and density, and its industrial application dates back to the 1930s. Repka division of pharmaceutical analysis, food and drug administration, 63101 st louis, mo. Hot melt extrusion is an efficient technology for producing solid molecular dispersions with considerable advantages over solventbased. March 2003 39 troubleshooter melt fracture or interfacial instability. Downstream processing from hotmelt extrusion towards. The interest in hot melt extrusion in the pharmaceutical industry has increased rapidly during the last years because of its many advantages over traditional production techniques.
Hotmelt extrusion hme processing was established in the early. Hme manufacture of amorphous dispersion involves the melting of a drug substance with an appropriate polymeric excipient in a corotating twinscrew extruder. Hotmelt extrusion is a sophisticated technology used to develop solid dispersion dosage forms for improved drug solubility and bioavailability, a common challenge for formulation scientists in the development of drug products today. Hotmelt extrusion hme has emerged as a promising technique to develop several types of pharmaceutical dosage. Technical data july, 2016 product description 3m hot melt adhesives are heat applied, 100% solids adhesives. In hotmelt extrusion, a blend of active substance api, polymer and plasticizer in powder form is transferred by. Hme is also a continuous process, which has been encouraged by the fda. Hotmelt extrusion hme is one of the most widely used processing techniques within the plastics industry.
Continuous mixing of solid dosage forms via hotmelt extrusion. Effective delivery of many of bcs class ii compounds with low solubility can be enabled with amorphous dispersions made by hot melt extrusion hme. Hot melt extrusion, pellets, implants, stents, extruders. Hotmelt extrusion hme is an established process that has been used since the early 1930s, predominately in the plastics manufacturing. Hot melt extrusion hme is a proven technology for bioavailability enhancement of poorly soluble apis. The extrudability of a polymer is mainly determined by t g or t m and melt viscosity. Stabilization of hotmelt extrusion formulations containing. Hot melt extrusion,particle sciences drug development services,2011,vol3,p.
Hot melt extrusion is an emerging technology for the continuous manufacture of drugs within the pharmaceutical industry. Hot melt extrusion processing for the pharmaceutical industry. Hotmelt extrusion is an efficient technology for producing solid molecular dispersions with considerable advantages over solventbased. Hot melt extrusion is extrusion compounding two or more ingredients which have been combined in defined proportions, distinguishable from their original state in that the characteristics of the whole is unique from that of the original constituents. Hot melt extrusion continuous extrusion process for pharmaceutical masses. Effective delivery of many of bcs class ii compounds with low solubility can be enabled with amorphous dispersions made by hotmelt extrusion hme. Stabilization of hot melt extrusion formulations containing solid solutions using polymer blends suneela prodduturi, kevin l. Today this technology has found its place in the array of pharmaceutical. Pdf pharmaceutical applications of hotmelt extrusion. Through science and innovation we provide our customers with products to meet the current and future needs of business and society. Hotmelt extrusion is a technique for manufacturing amorphous solid dispersions in which the drug substance is melted or dissolved within a dispersion carrier and mixed to produce and stabilize the amorphous form of the drug substance.
In hot melt extrusion, a blend of active substance api, polymer and plasticizer in powder form is transferred by. Hot melt extrusion is a well recognized technology in pharmaceutical industry today and is used in the preparation of variety of dosage forms and drug delivery systems. Furthermore, the hot melt extrusion process and hot melt extrusion equipment are readily scalable, from lab to pilot plantscale, through to commercial production. To combine the advantages of tablets and liquids, the research activities has been. Interest in pharmaceutical hme has greatly increased since the early 1980s as demonstrated by a steady increase in related patents. It then focuses on hme drug delivery systems, dosage forms and clinical studies including pharmacokinetics and bioavailability of hme products. Hot melt extrusion is a continuous process without solvent and provides better content uniformity with fewer unit operations. Hot melt extrusion hme is the processing of polymeric materials above their glass transition temperature tg in order to effect molecular level mixing of thermoplastic binders andor polymers and active compounds. Jun 22, 2012 eva hot melt glue stick production line yaoan plastic machinery co.
Solid dispersions by hotmelt extrusion pharmaceutical. Hot melt extrusion hme melting a substance and forcing it through an orifice under controlled conditions to form a new material is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot melt extrusion hme is a promising technology for the production of new chemical. The extrusion equipment is classified into three main categories. The materials used in hot melt extruded products must possess some.
Jun 26, 2012 hot melt extrusion hme melting a substance and forcing it through an orifice under controlled conditions to form a new material is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Interest in the pharmaceutical applications is growing rapidly and is evident from the increasing number of patents and publications. Stabilization of hotmelt extrusion formulations containing solid solutions using polymer blends suneela prodduturi, kevin l. Hotmelt extrusion hme has been revealed as a successful technology for a. In the more advanced twinscrew systems, extrusion of. The two main advantages of this process over other manufacturing processes are its ability to create very complex crosssections, and to work materials that are brittle, because the material only encounters compressive and shear stresses. He has a strong interest in solubilization including hot melt extrusion. Eva hot melt glue stick production line yaoan plastic machinery co.
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